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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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U Drape
O&M HALYARD, INC.
48057
In Commercial Distribution

  • 30680651480577 ()
  • 10680651480573 ()
48057

  • Patient surgical drape, single-use
U Handle
Paragon 28, Inc.
P99-150-2007
In Commercial Distribution

  • 00889795130914 ()
P99-150-2007

  • Surgical instrument handle, torque-limiting
U Pin
Rti Surgical, Inc.
999001
In Commercial Distribution

  • 00191083044460 ()
999001

  • General internal orthopaedic fixation system implantation kit
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ908421C
In Commercial Distribution

  • 10198459320484 ()
DYNJ908421C

  • General surgical procedure kit, non-medicated, single-use
U BAR
MEDLINE INDUSTRIES, INC.
DYNJ902374L
In Commercial Distribution

  • 10198459128899 ()
DYNJ902374L

  • General surgical procedure kit, non-medicated, single-use
U Drape
O&M HALYARD, INC.
48098
In Commercial Distribution

  • 30680651480980 ()
  • 20680651480983 ()
  • 90680651480982 ()
48098

  • Patient surgical drape, single-use, non-sterile
U Drape
O&M HALYARD, INC.
48069
In Commercial Distribution

  • 90680651480692 ()
  • 30680651480690 ()
48069

  • Patient surgical drape, single-use, non-sterile
TRIAL (U)
KURARAY NORITAKE DENTAL INC.
#4232-KA
In Commercial Distribution

  • EKUR004232KA1 ()


  • Dental composite resin
PLT (U)
KURARAY NORITAKE DENTAL INC.
#3191-KA
In Commercial Distribution

  • EKUR003191KA0 ()
  • EKUR003191KA1 ()


  • Dental composite resin
Syringe (U)
KURARAY NORITAKE DENTAL INC.
#3181-KA
In Commercial Distribution

  • EKUR003181KA1 ()


  • Dental composite resin
The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software
Eko mobile app for Android platforms for use with Eko products.
Eko Devices, Inc.
1.2.9
In Commercial Distribution

  • 00863609000341 ()


  • Medical equipment clinical data interfacing software
iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software
No Description
Boston Brace International, Inc.
SENSOR-MA-V1
In Commercial Distribution

  • 00860013109813 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 00850037806010 ()
MTL-103

  • Ambulatory insulin infusion pump software, patient-dosing
The SEER 1000 Apple App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 Apple App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.2.1
In Commercial Distribution

  • 04250903201202 ()
2067634-056

  • Electrocardiographic ambulatory recorder
The SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.0SP03
In Commercial Distribution

  • 04250903201196 ()
2067634-055

  • Electrocardiographic ambulatory recorder
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